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This is a split-mouth randomized clinical trial in which a new domiciliary oral care protocol with Biorepair Peribioma Toothpaste and Mousse is evaluated in periodontal patients.
This is a split-mouth randomized clinical trial that aims to suggest an innovative protocol for domiciliary oral care of periodontal patients. In details, home use of Biorepair Peribioma Toothpaste and Mousse is proposed as a support of professional hygiene sessions.
Patients that respond to the eligibility criteria and that sign the informed consent are recruited for periodontal therapy.The first professional hygiene session is performed at the baseline (T0); the following ones will be performed after 3 (T1) and 6 months (T2) from the baseline. In each session, periodontal indices of inflammation are detected; then, subgingival removal of plaque and tartar is performed, followed by glycine air-flow application in periodontal pockets. A microbiological test is perfomed in order to detect red and orange complex bacteria. At this time, patients are randomly allocated into two groups:
At the end of T1 and T2 professional session, a satisfaction survey about Peribioma Toothpaste and Mousse will ben given to the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group - Biorepair Peribioma Toothpaste + Mousse | Active Comparator | Domiciliary oral hygiene with Biorepair Peribioma Toothpaste in association with Peribioma Mousse twice a day until T2 session. |
|
| Control Group - Curasept Toothpaste (chlorhexidine 0,2%) | Active Comparator | Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) twice a day until T2 session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse | Other | Patients will use Biorepair Peribioma Toothpaste and Mousse for domiciliary oral hygiene twice a day until T2 session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BOP - Bleeding on Probing (percentage) | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%. | 3 and 6 months. |
| Change in BS - Bleeding Score | Scoring criteria:
| 3 and 6 months. |
| Change in SBI - Sulculus Bleeding Index (Muhulemann and Son, 1781) | Scoring criteria:
| 3 and 6 months. |
| Change in GI - Gingival Index (Loe and Silness, 1963) | Scoring criteria:
| 3 and 6 months. |
| Change in PPD - Probing Pocket Depth | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites. | 3 and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD. | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to Principal Investigator.
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This is a study in which patients are divided into two groups:
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| Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%) | Other | Patients will use Curasept Toothpaste (chlorhexidine 0,2%) for domiciliary oral hygiene twice a day until T2 session. |
|
| Change in CAL - Clinical Attachment Loss | Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ). | 3 and 6 months. |
| Change in Percentage of pathological sites | Evaluation of the presence of pathological probes expressed as a percentage. | 3 and 6 months. |
| Change in R - Gingival recession | Distance (in mm) between the gingival margin and the amelo-cemental junction. | 3 and 6 months. |
| Change in PI - Plaque Index (Silness and Löe, 1964) | Scoring criteria:
| 3 and 6 months. |
| Change in Evaluation of the total height of the adherent gingiva | Evaluation (in mm) of the total height of adherent gingiva. | 3 and 6 months. |
| Change in API - Approximal Plaque Index (Lange, 1986) | Following application of disclosing, a simple yes/no decision is made concerning whether the interproximal surfaces are covered by plaque (+) or not (-). The proportion of plaque-covered interproximal spaces is expressed as a percentage. Usually, in a given quadrant the interproximal spaces are scored from only one aspect (i.e. from the facial - Q2 and Q4 - or from the oral aspect - Q1 and Q3). | 3 and 6 months. |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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